The following terms as used herein have the meaning given below:
"Cholethiasis" is gallbladder disease due to stones.
The "mucosa" is the lining tissue of the gallbladder, prostate, and the urinary bladder.
"Necrosis" means the death of cells in tissue.
"Benign prostate hypertrophy (BPH)" is non-cancerous overgrowth of the prostate causing obstruction to urine outflow from the urinary bladder.
The standard treatment of cholelithiasis is surgical removal of the gallbladder. Until quite recently, the open surgical removal technique has been the treatment of choice, with over half a million procedures being performed annually. Standard cholecystostomies remove the offending organ, thereby decreasing the patient's chances of recurrent problems. This treatment has a number of significant disadvantages, however, including those associated with major surgery, lengthy hospitalization and several weeks absence from work; all of which may result in a major economic impact to the patient. Because of these serious drawbacks, improved techniques for the treatment of cholelithiasis have been long sought. This search has lead to a movement towards non-invasive methods for the management of gallbladder disease.
The treatment of cholelithiasis has more recently evolved to the use of a laparoscope. Some laparoscopic techniques for cholecystostomies involved the percutaneous chemical destruction of the gall bladder. For example, gallbladder ablation has been described by Becker et al. through a technique involving cystic duct occlusion combined with transcatheter chemical sclerotherapy, so as not to affect the bile ducts beyond the site of occlusion or otherwise cause other systemic or local side effects. In particular, Becker et al. describe cystic duct occlusion to prevent escape of sclerosant via the duct, followed by sclerotherapy of the tissue lining of the gallbladder with a sclerosant, e.g., ethanol or STS. This technique is cumbersome, however, inasmuch as it requires a separate step to achieve cystic duct occlusion and, at the same time, suffers from problems associated with introducing dangerous chemicals to a patient's body. Unfortunately, complications have been reported for these types of non-invasive procedures, including bile peritonitis and respiratory arrest which have occurred with the use of ether.
The use of a laparoscope as a diagnostic tool for pelvic and abdominal pain has enjoyed increased attention over the last few years as a result of advances in the use of fiber lasers and newer laparoscopic instrumentation.
The laparoscopic cholecystostomy has become a practical alternative to common surgical techniques because it reduces incisions and significantly decreases the amount of postoperative pain associated with the traditional techniques. Further advantages include short stay treatment and earlier resumption of normal activities; usually within as few as 7 days. Known laser laparoscopic cholecystostomy procedures are not without risk, however, and require a significant level of expertise and proficiency in the use of the fiber laser or electrosurgical equipment and all accessory instruments essential to prevent complications inherent to the laparoscope.
Accordingly, recently advanced methods for achieving laparoscopic cholecystostomies, including use of lasers, electrosurgery and chemical baths to effect necrosis of the affected tissue, while generally preferable to surgical removal of the gallbladder, suffer from disadvantages which have inhibited their widespread adoption.
The standard treatment of BPH is transurethral resection of the prostate. These procedures visualize the urinary bladder neck and the bulge of the hypertrophied prostate and remove part of the prostate by cutting and coagulative electrosurgery applied through the resectoscope. This treatment has significant disadvantages including exposure to electrosurgical burn, infusion of liquid distention media into the patient's vascular system that could cause congestive heart failure and serious electrolyte disturbances, hemorrhage from the prostate, and hospitalization.
Because of these problems, improved technology for treatment of BPH has been sought. Other approaches to this problem have been bladder dilation of the urinary bladder neck, cryocoagulation of the prostate, and drug therapies to shrink the prostate or improve urinary bladder function. None of these methods has effectively replaced the transurethral prostatectomy with the urologic resectoscope. In contrast, the apparatus and method of the present invention effectively cauterizes and destroys the surface mucosa and superficial layers of the prostate gland at the urinary bladder neck without the disadvantages of resectoscopic removal of the prostate.